Monograph: Plant Sterol Esters
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Date:
2022-01-21
NHPID name
Plant sterol esters ( US Govt Printing Office 2009 )Proper name(s)
Common name(s)
Plant Sterol EstersSource material
Route Of administration
Oral ( Chen et al. 2005 , Clifton et al. 2004 , Davidson et al. 2001 , de Jong et al. 2008 , FDA 2000 , FDA 2009 , Hendriks et al. 2003 , Hendriks et al. 1999 , Westrate and Meijer 1998 )Dosage form(s)
The acceptable pharmaceutical dosage forms suited to oral administration include, but are not limited to, chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons. This labelling standard is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.Use(s) or purpose(s)
Statement(s) to the effect of:
- Helps lower blood total and LDL cholesterol. (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)
- Helps maintain healthy cholesterol levels. (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)
Dose(s)
Duration of use
No statement is requiredRisk information
Statement(s) to the effect of:
Caution(s) and Warning(s): Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is requiredNon-medicinal ingredients
Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.Specifications
- The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
- The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).